IIVS | Documents & Resources
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Documents & Resources

IIVS BCOP Training Video – Spanish

October 16, 2017

This 13- minute video demonstrates how to perform the BCOP assay according to the Test Guidelines set forth for the assay by the Organization for Economic Co-operation and Development (OECD TG 437). The video focuses on steps that are critical to the success of the assay such as handling of the isolated cornea and removal of the test material from the cornea at the conclusion of the exposure time...

The 3T3 Neutral Red Uptake Phototoxicity Test – Spanish

October 6, 2017

This new training video explores a cell-based method for assessing Phototoxicity - or the potential for chemicals to cause damage after being exposed to light. The method is used widely around the world by many industries, including the cosmetics and pharmaceutical sectors. Disclaimer: Please note that the procedures shown in this video were for demonstration ...

Quality Considerations: Redefining Test Systems from Animals to Tissues and Beyond

August 28, 2017

Presented at the 2017 World Congress on Alternatives and Animals in the Life Sciences (WC10) A.K. Ulrey, RQAP-GLP; H.A. Raabe, M.S. The use of non-whole animal test methods transforms the way regulatory requirements are applied in preclinical testing. Recent global regulatory initiatives emphasize the importance of transitioning to human relevant assays and test systems that do not use animals. When these methods are moved from research into the regulated arena, GLP principles must be followed. The GLPs were originally written in the 1970s, when the vast majority of regulated research was performed using animals as the test system. Current innovative, alternative test systems include ex vivo tissues, manufactured biological systems, three dimensional tissue constructs, and cell cultures maintained in dynamic flow bioreactors. Each type of alternative test system raises new quality and compliance points to consider when used within a regulatory context. Just as the applications of these methods have advanced with regulatory acceptance, the quality control and compliance of these test systems must also progress.

Introducing the 3R Concepts into Pre-College Classrooms

August 28, 2017

Presented at the 2017 World Congress on Alternatives and Animals in the Life Sciences (WC10)

N. Green, G.-E. Costin, A. Miller, S. Leary, K. Lewis    This poster provides a snapshot of precollege teachers (46) within the U.S.—gauging their knowledge and familiarity of the 3Rs and non-animal testing methods (i.e. in vitro methods), initiative to address the topic in the classroom, and their students’ level of interest in the topic. While recognizing the ethical considerations related to animal experimentation, the current generation of teachers and students are also eager to understand the relevance, reliability, and reproducibility of in vitro methods as the modern wave of technologies in toxicology, and possible replacement of animal use for testing purposes. Our data indicate an education field eager to learn about new concepts that might impact our daily activities in an ethical way, and to get up to speed with advances in science.

Non-Animal Testing Approach to Address Biocompatibility Testing of Medical Devices Required by the United States Food and Drug Administration (US FDA)

August 28, 2017

Presented at the 2017 World Congress on Alternatives and Animals in the Life Sciences (WC10)

E. Hill, R. Curren, and G.-E. Costin Starting in December 2015, personal lubricants must receive pre-market approval from the US FDA Center for Devices and Radiological Health (CDRH) in order to be sold in the US. Part of the testing battery for biocompatibility includes the in vivo Rabbit Vaginal Irritation (RVI) test. We have created an Industry Consortium comprised of personal lubricants manufacturers and are working collaboratively with stakeholders and the US FDA to develop an in vitro testing approach to substitute for the RVI. Our Validation Program will analyze paired in vivo-in vitro data for vaginal irritation utilizing commercially available human reconstructed vaginal tissue models. A Prediction Model will be proposed that can be used for the safety assessment of personal lubricants. Our Validation Program proposal has been accepted in the Incubator Phase of the US FDA Medical Device Development Tool (MDDT) Pilot Program and is currently ongoing.

In Vitro Exposure Systems and Dosimetry Assessment Tools for Inhaled Tobacco Products: Workshop Proceedings, Conclusions and Paths Forward for In Vitro Model Use

August 17, 2017

In 2009, the passing of the Family Smoking Prevention and Tobacco Control Act facilitated the establishment of the FDA Center for Tobacco Products (CTP), and gave it regulatory authority over the marketing, manufacture and distribution of tobacco products, including those termed ‘modified risk’. On April 4-6, 2016, IIVS convened a workshop conference entitled, In Vitro Exposure Systems and Dosimetry Assessment Tools for Inhaled Tobacco Products, to bring together stakeholders representing regulatory agencies, academia and industry to address the research priorities articulated by the FDA CTP. This report includes the proceedings, recommendations, and outcome of the April 2016 technical workshop, including paths forward for developing and validating non-animal test methods for tobacco product smoke and next generation tobacco product aerosol/vapor exposures.  

Advances in Science: Next Generation of Lab Tools, Models and Testing Platforms Used in Predictive Toxicology

July 19, 2017

By Dr. Gertrude-Emilia Costin Toxicology testing platforms represent the basis of the human health risk assessment process that determines whether a material or product may induce harm to humans upon exposure. Historically, safety assessment of raw ingredients or finished formulations has been performed using animal-based test methods (in vivo) that provide whole organism responses to toxicants. Due to the large number of products launched by industry continuously, modern toxicology shifted in recent years towards the use of novel, fast and reliable alternative methods, ranging from in silico to in chemico or in vitro, of which some are validated for regulatory purposes. The manuscript also addresses emerging technologies in the form of “organ/body-on-a-chip” platforms which announce to be instrumental in allowing alternative systems to in vivo models to assess systemic toxic effects induced by chemicals.

Webinar: Skin Tone Modulation: In Vitro Pre-clinical and Clinical Efficacy Testing Strategies and Innovative Solutions in Cosmetics

July 13, 2017

Addressing uneven skin tone often associated with photo-aging is a key area of interest in the cosmetic industry. The design of novel, safe, and efficacious actives and ingredients capable of inducing subtle changes in skin tone can be accomplished using modern, relevant and reliable pre-clinical testing strategies prior to clinical assessment. During this one-hour webinar, IIVS Study Director...

Navigating the Claim Substantiation Maze in Cosmetics Industry

June 15, 2017

Read this article by IIVS study director Dr. Gertrude-Emilia Costin and biologist Asha Shravanthi Pidathala in the June 2017 issue of Eurocosmetics.  The article examines modern, relevant, and reliable in vitro testing strategies using pigmented tissue models that assess the capacity of ingredients and formulations that impact skin tone.